- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00019591
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
A Phase I/II Trial of Vaccination With Mutant Ras Peptide-Pulsed Dendritic Cells in the Treatment of HLA A2.1 Positive Patients With Colorectal Cancer
RATIONALE: Vaccines may make the body build an immune response that will kill cancer cells. Combining vaccine therapy with interleukin-2 may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have locally advanced or metastatic colorectal cancer.
Обзор исследования
Статус
Условия
Подробное описание
OBJECTIVES:
- Determine the frequency of immunologic response in patients with locally advanced or metastatic colorectal cancer treated with ras peptide-pulsed dendritic cell vaccine with or without interleukin-2.
- Determine the tumor response and survival time in patients with metastatic colorectal cancer treated with vaccine plus interleukin-2.
- Determine the time to progression in patients with locally advanced colorectal cancer treated with adjuvant vaccine.
OUTLINE: Patients are assigned to 1 of 2 treatment groups according to extent of disease. Patients with prior locally advanced disease are assigned to treatment group A, while those with metastatic disease are assigned to treatment group B.
- Group A: Patients are vaccinated against influenza on day -6. Patients undergo collection of peripheral blood mononuclear cells (PBMC) on day -4. The PBMC are cultured with sargramostim (GM-CSF) and interleukin-4 for 5 days and CD40 ligand for 24 hours and then pulsed for 2 hours with the appropriate peptide to form a vaccine. Patients receive ras peptide-pulsed dendritic cell vaccine IV over 5 minutes on days 1, 15, 29, 43, and 57.
- Group B: Patients undergo collection of PBMC and receive vaccination as in group A. Patients also receive interleukin-2 subcutaneously on days 2-6 and 9-13.
Treatment in both groups repeats every 2 weeks for up to 5 vaccinations in the absence of disease progression or unacceptable toxicity.
Patients are followed on days 75, 90, 120, and 365.
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 3 years.
Тип исследования
Фаза
- Фаза 2
- Фаза 1
Контакты и местонахождение
Места учебы
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Maryland
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Bethesda, Maryland, Соединенные Штаты, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Tennessee
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Nashville, Tennessee, Соединенные Штаты, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
DISEASE CHARACTERISTICS:
- Histologically confirmed locally advanced or metastatic colorectal cancer
- Metastatic disease must be radiologically proven
- HLA-A2-1 positive
- Locally advanced disease must have had prior resection or incomplete resection with poor prognosis
Locally advanced disease includes:
- Stage III or IV colon cancer (T4 or any T, N2-3, M0)
- Stage III or IV rectal cancer (T4 or T3, N1-3)
- Resectable or unresectable T4 disease after radiotherapy, chemotherapy, and/or surgery
- Absence of measurable disease but more than a 50% chance of recurrence
- Completely resected or locally advanced disease may have had conventional therapy completed within 1-12 months (surgery alone, with or without adjuvant chemotherapy and/or radiotherapy) prior to study entry
Metastatic disease patients must have bidimensionally measurable disease
- Bone lesions with well-demarcated borders allowed
- Lesions seen only on bone scan, pleural effusions, ascites, and changes in carcinoembryonic antigen are not considered measurable disease
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Lymphocyte count at least 470/mm^3
- Granulocyte count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2.0 mg/dL*
- SGOT no greater than 4 times upper limit of normal (ULN) (2.5 times ULN for adjuvant patients)*
- Albumin at least 3 g/dL
- No active viral hepatitis
- No evidence of chronic infection due to hepatitis C
- Hepatitis B surface antigen negative NOTE: *Unless due to metastatic disease
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No history of cardiac failure, significant arrhythmias, or coronary artery disease (metastatic disease patients only)
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No prior malignancy with a 50% chance of recurrence within 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
- No medical or psychiatric condition that would preclude compliance
- No serious medical condition that would preclude apheresis
- No serious infection
- No uncontrolled thyroid disease (metastatic disease patients only)
- Patients with an allergy to eggs are allowed but are not vaccinated against influenza during study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunologic therapy directed at the cellular immune system
Chemotherapy:
- See Disease Characteristics
- Prior chemotherapy for metastatic disease allowed
- At least 4 weeks since prior chemotherapy
- No concurrent chemotherapy or anticipated need for chemotherapy for 2 months after vaccinations
Endocrine therapy:
- At least 4 weeks since prior supraphysiologic steroid therapy
Radiotherapy:
- See Disease Characteristics
- Prior radiotherapy for metastatic disease allowed
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- Prior surgery for metastatic disease allowed
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
|---|
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Response rate every 3 months for up to a year after completion of study treatment
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Соавторы и исследователи
Спонсор
Следователи
- Учебный стул: John E. Janik, MD, NCI - Metabolism Branch;MET
Даты записи исследования
Изучение основных дат
Начало исследования
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания пищеварительной системы
- Новообразования
- Новообразования по локализации
- Желудочно-кишечные новообразования
- Новообразования пищеварительной системы
- Желудочно-кишечные заболевания
- Заболевания толстой кишки
- Кишечные заболевания
- Новообразования кишечника
- Заболевания прямой кишки
- Колоректальные новообразования
- Противоинфекционные агенты
- Противовирусные агенты
- Агенты против ВИЧ
- Антиретровирусные агенты
- Противоопухолевые агенты
- Альдеслейкин
Другие идентификационные номера исследования
- CDR0000066874
- NCI-99-C-0023L
- NCI-T98-0034
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